FDA official announcements and press releases

Dr. Leana Wen Calls for FDA to Authorize H5N1 Vaccine for Vulnerable Americans Amid 66 Human Cases

Dec 29, 2024, 05:35 PM

Dr. Leana Wen, former Commissioner of the Baltimore City Health Department, is urging the Biden administration to expedite FDA authorization of the existing H5N1 bird flu vaccine and distribute approximately five million doses to vulnerable Americans before President-elect Donald Trump takes office. Wen expressed concern over a reported mutation in a Louisiana patient and noted that there are already 66 confirmed human cases, stressing that this number is likely an undercount due to insufficient testing. She emphasized the urgent need for increased testing, including rapid and home tests, particularly for farm workers, to prevent a potential pandemic. Other health experts have issued similar warnings, cautioning that the bird flu could mutate and become a major threat.